Would Democrats wreck America to win in 2020?

By Lowell Ponte
Published December 9, 2018

The diverse menagerie of Democratic presidential candidates for 2020 already looks like the bar scene in “Star Wars.” But left-of-center star Bruce Springsteen sees no Democrat now running who can beat incumbent President Donald Trump, because none has Trump’s charismatic ability to speak to working-class Americans.

Democratic analysts are frightened for their party’s future. Prior to the 2018 midterm election, voters had denied Democrats control of the House of Representatives, Senate and White House – which spells disaster for a party that buys its voters with taxpayer dollars and government favors.

Democrats predicted a “blue wave” in the 2018 midterms, but won only about 25 seats to barely claim control of the House of Representatives. More than 40 Republican members of Congress refused to seek reelection; without those GOP dropouts, Republicans almost certainly would have kept Democrats a minority in the House.

Democrats also stole an additional dozen or so seats in Democrat-ruled states such as California, where Republicans who won on election night were later drowned by a late flood of mysterious pro-Democratic “ballots from nowhere” that everybody knows were fraudulent. (This is why George Soros spent millions electing leftist Secretaries of State to manipulate state ballot recounts.) Voters increased the GOP Senate majority, showing how little love they have for Democrats.

So what must Democrats do to win in 2020?

TRENDING: Obama drops coronavirus bombshell: It’s all due to climate change!

“[The] way you get rid of Trump is a crashing economy. So, please, bring on the recession,” says leftist HBO comic Bill Maher. “Sorry if that hurts people … [but] a recession is a survivable event; what Trump is doing to this country is not.”

Actually, the country is better than it has been for decades. But Maher rightly understands that if Trump continues to succeed, the Democratic Party and its socialist boot on the necks of Americans will be finished.

“You cannot be civil with a political party that wants to destroy what you stand for,” Hillary Clinton says, declaring that “civility can only return” when her Democratic Party again controls the government. Until voters restore leftist politicians to their entitled dominion as our superiors, the Democrats will turn politics into war, resistance, and unwavering hatred, because their unwanted collectivist party is fighting dirty for its survival.

And if a prosperous economy could make Trump successful and get him re-elected, do not doubt that anti-capitalist Democrats will do everything in their power to economically ruin an America they cannot rule.

Democrats have already made it clear they hate our capitalism, individualism, independence and our government-limiting Constitution. As globalists who favor world government, most Democrats would gleefully erase our borders, bankrupt our government with a giant tidal wave of illegal immigrants who vote Democratic, and cheer as our country disappears from their new brave new politically correct world.

In wrecking the economy, Democrats will rely on a key ally – the leftist mainstream media, which will blame every economic problem not on Democratic taxes, regulations and economic manipulations, but on President Trump’s “failed policies.” Democrats will control the House, where every taxing and spending bill must originate.

Such Democratic sabotage of our economy may already be under way. On Dec. 1, as President Trump was at the G-20 meeting in Buenos Aires, Argentina – negotiating with Chinese leader Xi Jinping how to make trade more fair and less warlike between our two nations – something unprecedented happened in Canada. Meng Wanzhou, the Chief Financial Officer (and founder’s daughter) of China’s telecom giant Huawei, was suddenly arrested on a U.S. warrant charging the company with violating the Iran embargo.

As word of the arrest spread, China threatened to “take all measures” to show its outrage. The New York Stock Exchange plunged, likely wiping out all gains in 2018, because Trump now faced a trade war with China and a likely recession.

“Who ordered the arrest, and why?” asked famed financial columnist “Spengler” (David Goldman) in Asia Times. “It is unlikely that the president would escalate the conflict with China with [this] arrest … on the same day he sought to deescalate the trade war.”

It could be, wrote Spengler, “that Trump’s enemies in the permanent bureaucracy simply want to prevent the president from negotiating a deal with China that would enhance his image and remove risks to economic growth.”

In the latest issue of “Real Money Perspectives,” Craig R. Smith and I analyze many ways Democrats may cripple the economy to undermine President Trump, and how you can protect your family’s assets from their various tactics of economic political warfare against Americans in 2019 and 2020.

Lowell Ponte is a former think tank futurist and retired roving editor at Reader’s Digest. He is coauthor, with Craig R. Smith, of “Money, Morality & the Machine: Smith’s Law in an Unethical, Over-Governed Age.” Ponte’s articles have appeared in the Wall Street Journal, the New York Times and major other publications. Get your complimentary article from Real Money Perspectives by calling 1-800-630-1492.

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DOJ IG Checked 29 More FBI Spy Warrants, and Found Problems with All of Them

April 1, 2020
by Chuck Ross

 

The Justice Department’s Office of the Inspector General has a “lack of confidence” in the FBI’s procedures to validate information used to obtain spy warrants on American citizens, the watchdog said in a report released Tuesday.

The Office of the Inspector General (OIG) found errors in all 29 of the Foreign Intelligence Surveillance Act (FISA) warrant applications that were subject to the review.

The audit is a follow-up to an investigation of the FBI’s surveillance of Carter Page, the former Trump campaign aide.

A report of that investigation blasted the FBI for making dozens of errors and omissions in four applications the bureau submitted to the Foreign Intelligence Surveillance Court (FISC). The findings prompted the Justice Department to retract two of the warrants because they were based on faulty information.

The OIG review released Tuesday suggests that the FBI’s problems are widespread.

“As a result of our audit work to date and as described below, we do not have confidence that the FBI has executed its Woods Procedures in compliance with FBI policy,” the OIG said in a memo to FBI Director Christopher Wray.

As part of the review, the OIG reviewed documents known as Woods Files for 29 applications filed from between October 2014 and September 2019.

FBI agents and officials are supposed to provide proof in the Woods Files for every factual statement made in applications submitted to the FISA Court in order to show that the applications are “scrupulously accurate.”

The OIG investigation of the Carter Page FISA applications found numerous errors with the Woods Files used in that investigation. The OIG report, released Dec. 9, 2019, found that FBI agents working the case failed to validate information from the infamous Steele dossier.

According to the latest audit, OIG investigators were unable to locate four Woods Files for the 29 FISA applications, suggesting that FBI agents never filled them out.

The OIG audit also identified “apparent errors or inadequately support facts” in the 25 applications that were available for review.

The audit also found that the FBI and Justice Department’s National Security Division did not conduct appropriate oversight of FISA procedures.

The OIG did not assess whether the errors were material, or that they would have changed the FBI’s decision to file the applications, or the FISA Court’s decision to grant them.

The audit does not provide specific information about the applications that were reviewed.

An OIG report released Dec. 9, 2019, found that the FBI made at least 17 significant errors and omissions in the final Carter Page FISA application. The Justice Department deemed the final two Page FISAs to be invalid because of all of the errors.

– – –

Chuck Ross is a reporter at Daily Caller News Foundation.

 

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The Media And Their Billions Large Blind Mob

[I reprint this article because it raises some important points both about the novel virus in circulation and the media propaganda regarding it. In the US the media is clearly pushing the hysteria and airing fake news for partisan political purposes. This author points to financial motivations for the behavior of and reporting by the media. I know less about finances and so cannot speak to those points, but believe this piece contains important information and present it for those of you with more expertise. TC]

by  on March 30, 2020
left: Mark Rutte, in a major speech to the Dutch People, for the very first time in his 10 year as Prime Minister, showed some actual leadership and spoke the truth to the hysterical mob: “Most of you will get Corona, and you’ll be fine”

In the U.S. alone, the flu has caused an estimated 36 million illnesses, 370,000 hospitalizations and 22,000 deaths this season alone but we only hear about the 2500 Corona supposed deaths.
The West is just getting destroyed by a New World Order Media directed mob, in the best traditions as described in the protocols.

By Anthony Migchels, for Henrymakow.com and Real Currencies

The Media have just whipped up a huge, worldwide, billions large, blind mob, with a totally bullshit narrative.
They have CRUSHED all major States, their institutions, everything, forcing them into complete destruction. Of order. The economy. Our most fundamental human rights: to make our living. To leave our homes.

migchel=graph.png

This graph has been published by the Dutch Government. It shows mortality in the Netherlands over the last few years, per week.
It shows a very small peak over the last few weeks: at the top of the ‘corona pandemic’, there have been 500 more deaths in the Netherlands than usual. Average age: 75.
This ‘500’ ‘peak’ is just completely insignificant to the ‘big’ peak in early 2018, with actually about 9000 extra deaths during the flu season. This actual peak was a non-issue, it happens all the time in all countries.
Again, this shows what is going on: Governments everywhere in the West are doing their real damn best to just report the facts.
I know that people working in the RIVM, the Dutch CDC, are completely NOT on board with this entirely fabricated panic. I ask them to go on Social Media, and tell everybody that this is all complete bullshit.
And believe me: it’s very uncomfortable for me to side with an outlet like the RIVM, who are mostly known for their vaccine pushing.
But this is a Media Blitz. By the International Media. Completely.It cannot be stressed enough that the media is are all owned by 5 or 10 huge transnational corporations, in turn owned by the biggest banks in the World.

Western governments are trying to tell the truth, while the Media are just absolutely TRASHING the OBVIOUS facts.
1) Trump has for weeks now been saying, consistently, “this is nothing, we got it under control, this is just a flu.” He didn’t want to drop a nuclear bomb on working people and small business! At all! He’s getting absolutely annihilated by the Fake News lot.
2) Bolsonaro has come out blazing it’s a media attack, and that people will be livid when they find out how they have been taken by the noose by them. And that the economy must be restarted.
3) Two weeks ago, the Italian Government has reported that 99% of those supposedly ‘dying of corona’ are 80 year olds already dying of myriad lethal health issues.
4) Mark Rutte, in a major speech to the Dutch People, for the very first time in his 10 year as Prime Minister, showed some actual leadership and spoke the truth to the hysterical mob: “Most of you will get Corona, and you’ll be fine”.
Dutch Government reporting on the facts has been entirely professional and impeccable.
5) Already since March 19th, the UK Government has taken ‘corona’ off their list of dangerous diseases.
And now Boris Johnson is ‘self isolating’ and ‘in quarantine’ because he has ‘been diagnosed’………….with a ‘virus’ that most of us will catch, 99% of us without even noticing, and a few of us feeling crappy for a few days.
CONCLUSION
This is what has happened: the Media, Internationally, centrally coordinated, has DESTROYED our States and Institutions and Truth and Economy and Liberty and Love with an ENTIRELY fabricated ‘pandemic’, putting the masses into a fear psychosis.
They have whipped up a huge, worldwide blind mob, billions of people, in total fear, gripped by delusion and fear and a faux sense of togetherness in the face of an ‘invisible enemy’.
And States, Institutions, the Truth, our Economy, men and women with a still functioning brain and heart, they are forced to bow to their will. Forced into submission to a few dominant men behind the scenes, and their mob.
Their domination is total. An immense show of force.
To the individual members of the Mob, I’ll say this: “You may want to snap out of it now.”
And to those goading them: “Well, you have fooled even many of the elect.
As it was foretold you would.
You will have a few ‘victories’ still.  But I know, that you know, that your time is almost up.”Related:
Interview: In Case You Haven’t Noticed, This Is A Bolshevist Takeover West Wide
NWO Magick: A Faux ‘Pandemic’, And A Very, Very Real Financial Collapse

As a bonus: watch this and weep, as James Corbett lays out what is actually happening: they are stealing TRILLIONS, destroying small business, and wheeling in their ‘new economy’.

https://www.youtube.com/watch?v=ZlTHjAuqRHs&feature=youtu.be

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How deadly is the coronavirus? It’s still far from clear

by Dr. John Lee

There is room for different interpretations of the data

March 28, 2020

In announcing the most far-reaching restrictions on personal freedom in the history of our nation, Boris Johnson resolutely followed the scientific advice that he had been given. The advisers to the government seem calm and collected, with a solid consensus among them. In the face of a new viral threat, with numbers of cases surging daily, I’m not sure that any prime minister would have acted very differently.

But I’d like to raise some perspectives that have hardly been aired in the past weeks, and which point to an interpretation of the figures rather different from that which the government is acting on. I’m a recently-retired Professor of Pathology and NHS consultant pathologist, and have spent most of my adult life in healthcare and science – fields which, all too often, are characterised by doubt rather than certainty. There is room for different interpretations of the current data. If some of these other interpretations are correct, or at least nearer to the truth, then conclusions about the actions required will change correspondingly.

The simplest way to judge whether we have an exceptionally lethal disease is to look at the death rates. Are more people dying than we would expect to die anyway in a given week or month? Statistically, we would expect about 51,000 to die in Britain this month. At the time of writing, 422 deaths are linked to Covid-19 — so 0.8 per cent of that expected total. On a global basis, we’d expect 14 million to die over the first three months of the year. The world’s 18,944 coronavirus deaths represent 0.14 per cent of that total. These figures might shoot up but they are, right now, lower than other infectious diseases that we live with (such as flu). Not figures that would, in and of themselves, cause drastic global reactions.

Initial reported figures from China and Italy suggested a death rate of 5 per cent to 15 per cent, similar to Spanish flu. Given that cases were increasing exponentially, this raised the prospect of death rates that no healthcare system in the world would be able to cope with. The need to avoid this scenario is the justification for measures being implemented: the Spanish flu is believed to have infected about one in four of the world’s population between 1918 and 1920, or roughly 500 million people with 50 million deaths. We developed pandemic emergency plans, ready to snap into action in case this happened again.

At the time of writing, the UK’s 422 deaths and 8,077 known cases give an apparent death rate of 5 per cent. This is often cited as a cause for concern, contrasted with the mortality rate of seasonal flu, which is estimated at about 0.1 per cent. But we ought to look very carefully at the data. Are these figures really comparable?

Most of the UK testing has been in hospitals, where there is a high concentration of patients susceptible to the effects of any infection. As anyone who has worked with sick people will know, any testing regime that is based only in hospitals will over-estimate the virulence of an infection. Also, we’re only dealing with those Covid-19 cases that have made people sick enough or worried enough to get tested. There will be many more unaware that they have the virus, with either no symptoms, or mild ones.

That’s why, when Britain had 590 diagnosed cases, Sir Patrick Vallance, the government’s chief scientific adviser, suggested that the real figure was probably between 5,000 and 10,000 cases, ten to 20 times higher. If he’s right, the headline death rate due to this virus is likely to be ten to 20 times lower, say 0.25 per cent to 0.5 per cent. That puts the Covid-19 mortality rate in the range associated with infections like flu.

But there’s another, potentially even more serious problem: the way that deaths are recorded. If someone dies of a respiratory infection in the UK, the specific cause of the infection is not usually recorded, unless the illness is a rare ‘notifiable disease’. So the vast majority of respiratory deaths in the UK are recorded as bronchopneumonia, pneumonia, old age or a similar designation. We don’t really test for flu, or other seasonal infections. If the patient has, say, cancer, motor neurone disease or another serious disease, this will be recorded as the cause of death, even if the final illness was a respiratory infection. This means UK certifications normally under-record deaths due to respiratory infections.

Now look at what has happened since the emergence of Covid-19. The list of notifiable diseases has been updated. This list — as well as containing smallpox (which has been extinct for many years) and conditions such as anthrax, brucellosis, plague and rabies (which most UK doctors will never see in their entire careers) — has now been amended to include Covid-19. But not flu. That means every positive test for Covid-19 must be notified, in a way that it just would not be for flu or most other infections.

In the current climate, anyone with a positive test for Covid-19 will certainly be known to clinical staff looking after them: if any of these patients dies, staff will have to record the Covid-19 designation on the death certificate — contrary to usual practice for most infections of this kind. There is a big difference between Covid-19 causing death, and Covid-19 being found in someone who died of other causes. Making Covid-19 notifiable might give the appearance of it causing increasing numbers of deaths, whether this is true or not. It might appear far more of a killer than flu, simply because of the way deaths are recorded.

If we take drastic measures to reduce the incidence of Covid-19, it follows that the deaths will also go down. We risk being convinced that we have averted something that was never really going to be as severe as we feared. This unusual way of reporting Covid-19 deaths explains the clear finding that most of its victims have underlying conditions — and would normally be susceptible to other seasonal viruses, which are virtually never recorded as a specific cause of death.

Let us also consider the Covid-19 graphs, showing an exponential rise in cases — and deaths. They can look alarming. But if we tracked flu or other seasonal viruses in the same way, we would also see an exponential increase. We would also see some countries behind others, and striking fatality rates. The United States Centers for Disease Control, for example, publishes weekly estimates of flu cases. The latest figures show that since September, flu has infected 38 million Americans, hospitalised 390,000 and killed 23,000. This does not cause public alarm because flu is familiar.

The data on Covid-19 differs wildly from country to country. Look at the figures for Italy and Germany. At the time of writing, Italy has 69,176 recorded cases and 6,820 deaths, a rate of 9.9 per cent. Germany has 32,986 cases and 157 deaths, a rate of 0.5 per cent. Do we think that the strain of virus is so different in these nearby countries as to virtually represent different diseases? Or that the populations are so different in their susceptibility to the virus that the death rate can vary more than twentyfold? If not, we ought to suspect systematic error, that the Covid-19 data we are seeing from different countries is not directly comparable.

Look at other rates: Spain 7.1 per cent, US 1.3 per cent, Switzerland 1.3 per cent, France 4.3 per cent, South Korea 1.3 per cent, Iran 7.8 per cent. We may very well be comparing apples with oranges. Recording cases where there was a positive test for the virus is a very different thing to recording the virus as the main cause of death.

Early evidence from Iceland, a country with a very strong organisation for wide testing within the population, suggests that as many as 50 per cent of infections are almost completely asymptomatic. Most of the rest are relatively minor. In fact, Iceland’s figures, 648 cases and two attributed deaths, give a death rate of 0.3 per cent. As population testing becomes more widespread elsewhere in the world, we will find a greater and greater proportion of cases where infections have already occurred and caused only mild effects. In fact, as time goes on, this will become generally truer too, because most infections tend to decrease in virulence as an epidemic progresses.

One pretty clear indicator is death. If a new infection is causing many extra people to die (as opposed to an infection present in people who would have died anyway) then it will cause an increase in the overall death rate. But we have yet to see any statistical evidence for excess deaths, in any part of the world.

Covid-19 can clearly cause serious respiratory tract compromise in some patients, especially those with chest issues, and in smokers. The elderly are probably more at risk, as they are for infections of any kind. The average age of those dying in Italy is 78.5 years, with almost nine in ten fatalities among the over-70s. The life expectancy in Italy — that is, the number of years you can expect to live to from birth, all things being equal — is 82.5 years. But all things are not equal when a new seasonal virus goes around.

It certainly seems reasonable, now, that a degree of social distancing should be maintained for a while, especially for the elderly and the immune-suppressed. But when drastic measures are introduced, they should be based on clear evidence. In the case of Covid-19, the evidence is not clear. The UK’s lockdown has been informed by modelling of what might happen. More needs to be known about these models. Do they correct for age, pre-existing conditions, changing virulence, the effects of death certification and other factors? Tweak any of these assumptions and the outcome (and predicted death toll) can change radically.

Much of the response to Covid-19 seems explained by the fact that we are watching this virus in a way that no virus has been watched before. The scenes from the Italian hospitals have been shocking, and make for grim television. But television is not science.

Clearly, the various lockdowns will slow the spread of Covid-19 so there will be fewer cases. When we relax the measures, there will be more cases again. But this need not be a reason to keep the lockdown: the spread of cases is only something to fear if we are dealing with an unusually lethal virus. That’s why the way we record data will be hugely important. Unless we tighten criteria for recording death due only to the virus (as opposed to it being present in those who died from other conditions), the official figures may show a lot more deaths apparently caused by the virus than is actually the case. What then? How do we measure the health consequences of taking people’s lives, jobs, leisure and purpose away from them to protect them from an anticipated threat? Which causes least harm?

The moral debate is not lives vs money. It is lives vs lives. It will take months, perhaps years, if ever, before we can assess the wider implications of what we are doing. The damage to children’s education, the excess suicides, the increase in mental health problems, the taking away of resources from other health problems that we were dealing with effectively. Those who need medical help now but won’t seek it, or might not be offered it. And what about the effects on food production and global commerce, that will have unquantifiable consequences for people of all ages, perhaps especially in developing economies?

Governments everywhere say they are responding to the science. The policies in the UK are not the government’s fault. They are trying to act responsibly based on the scientific advice given. But governments must remember that rushed science is almost always bad science. We have decided on policies of extraordinary magnitude without concrete evidence of excess harm already occurring, and without proper scrutiny of the science used to justify them.

In the next few days and weeks, we must continue to look critically and dispassionately at the Covid-19 evidence as it comes in. Above all else, we must keep an open mind — and look for what is, not for what we fear might be.

John Lee is a recently retired professor of pathology and a former NHS consultant pathologist.

WRITTEN BY Dr. John Lee
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Los Angeles Times and Bloomberg News: Federal stockpile of N95 masks was depleted under Obama and never restocked

 

The national shortage of N95 respirator masks can be traced back to 2009 after the H1N1 swine flu pandemic, when the Obama administration was advised to replenish a national stockpile but did not, according to reports from Bloomberg News and the Los Angeles Times.

The Trump administration is scrambling to replenish a stockpile of protective medical gear for healthcare workers and patients as the coronavirus sweeps across the nation. N95 respirator masks are one of the most needed medical supplies amid the outbreak.

The George W. Bush administration published the National Strategy for Pandemic Influenza plan in 2005, which called on the federal government to distribute medical supplies from the Strategic National Stockpile governed by the Health and Human Services Department in the event of an outbreak.

In 2009, the H1N1 outbreak hit the United States, leading to 274,304 hospitalizations, 12,469 deaths, and a depletion of N95 respirator masks.

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A federally backed task force and a safety equipment organization both recommended to the Obama administration that the stockpile be replenished with the 100 million masks used after the H1N1 outbreak.

Charles Johnson, president of the International Safety Equipment Association, said that advice was never heeded.

“Our association is unaware of any major effort to restore the stockpile to cover that drawdown,” he said.

HHS Secretary Alex Azar reported last month that only 12 million N95 masks were available in the stockpile, “a tiny fraction of the 3.5 billion masks one of Azar’s deputies later testified the nation’s healthcare system would need,” the Los Angeles Times noted.

Bloomberg News reported similar findings last week, noting, “After the H1N1 influenza outbreak in 2009, which triggered a nationwide shortage of masks and caused a 2- to 3-year backlog [of] orders for the N95 variety, the stockpile distributed about three-quarters of its inventory and didn’t build back the supply.”

Bloomberg reported that the Trump administration had asked construction companies to “donate their inventory of N95 masks to your local hospital and forgo additional orders of those industrial masks” and the Defense Department would provide 5 million N95 masks and 2,000 ventilators to help bridge the gap.

Johns Hopkins University’s coronavirus tracker reported 35,225 confirmed COVID-19 cases in the U.S. as of Monday.

Vice President Mike Pence, who heads the administration’s coronavirus task force, said on Sunday that a quarter-million people had been tested for the virus, with 9 out of 10 people testing negative.

“The FDA is working with manufacturers around the company to come up with faster, more innovative tests,” he said.

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Timeline: The Regulations—and Regulators—That Delayed Coronavirus Testing

There have been three major regulatory barriers so far.

Addressing the media alongside the coronavirus task force on Thursday, Donald Trump said he would “slash red tape like nobody has even done it before” to get approval for coronavirus treatments.

That would be a welcome development indeed. What’s unfortunate is that there was no similar push at the beginning of the crisis to expedite coronavirus testing. The U.S. response to the pandemic has been hampered at every level due to insufficient testing capacity.

The first coronavirus case in the U.S. and South Korea was detected on January 21. Since then, South Korea has effectively contained the coronavirus without shutting down its economy or quarantining tens of millions of people. Instead, the Korean government has pursued a “trace, test, and treat” strategy that identifies and isolates those infected with the coronavirus while allowing healthy people to go about their normal lives. Hong Kong, Singapore, and Taiwan have also managed to contain the virus via a combination of travel restrictions, social distancing, and heightened hygiene.

Unfortunately, the United States has not made testing widely available and now various regions are being forced to impose severe economic and social lockdowns. As of March 17, the U.S. had tested only about 125 people per million. South Korea had tested more than 5,000 people per million. Between early February and mid-March, the U.S. lost six crucial weeks because regulators stuck to rigid regulations instead of adapting as new information came in. While these rules might have made sense in normal times, they proved disastrous in a pandemic.

Under ordinary circumstances, the cost of using an imperfect diagnostic test often outweighs the benefit. But when public health officials need to contain a novel and highly contagious disease, speed matters more than perfection. The lessons from this debacle are clear: The FDA needs to have plans in place prior to a pandemic for public labs and private companies to produce their own test kits. A distributed strategy would be much more resilient to errors, in contrast to the single point of failure created by the FDA in this crisis. Poor planning and mindless adherence to peacetime regulations led to this abysmal result:

Source: NYT

Source: NYT

How did the U.S. government only manage to produce a fraction as many testing kits as its peer countries? There have been three major regulatory barriers so far to scaling up testing by public labs and private companies: 1) obtaining an Emergency Use Authorization (EUA); 2) being certified to perform high-complexity testing consistent with requirements under Clinical Laboratory Improvement Amendments (CLIA); and 3) complying with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Common Rule related to the protection of human research subjects. On the demand side, narrow restrictions on who qualified for testing prevented the U.S. from adequately using what capacity it did have.

It’s important to understand the broader context of the FDA regulatory process. It often takes more than a decade for a new diagnostic test or therapeutic drug to earn FDA approval. Fortunately, the FDA already has the ability to let public labs and private companies circumvent the regular approval process under its Emergency Use Authorization (EUA) authority. So, why was this emergency authority ineffective in scaling up coronavirus testing? Here is a timeline of the most important events:

December 31: The WHO received reports of dozens of cases of pneumonia of unknown cause in Wuhan City, Hubei Province, China.*

January 9: China announced it has mapped the genome of the novel coronavirus.

January 21. The CDC confirmed the first case of coronavirus in the United States in the state of Washington and announced it had finalized its coronavirus testing protocol.

January 23: German researchers published the first paper describing a testing protocol for the novel coronavirus. The WHO would later use this protocol as the basis for the millions of tests it produced for less-developed countries.

January 30: The WHO declared a global health emergency.

January 31: HHS Secretary Alex Azar declared a public health emergency, which initiated a new requirement—labs that wanted to conduct their own coronavirus tests must first obtain an emergency use authorization (EUA) from the FDA. According to reporting from Reuters, the emergency declaration made it more difficult to expand testing outside the CDC:

That’s because the declaration required diagnostic tests developed by individual labs, such as those at hospitals or universities, to undergo greater scrutiny than in non-emergencies—presumably because the stakes are higher.

“Paradoxically, it increased regulations on diagnostics while it created an easier pathway for vaccines and antivirals,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security. “There was a real foul-up with diagnostic tests that has exposed a flaw in the United States’ pandemic response plan.”

This was the moment when the wheels came off the bus. Keith Jerome, the lab director at the University of Washington Virology Lab in Seattle, told The New Yorker how perverse this heightened standard was from a public health perspective:

From the point of view of the academic labs, we look at it, like, when there’s any run-of-the-mill virus that people are used to, they trust us to make a test. But when there’s a big emergency and we feel like we should really do something, it gets hard. It’s a little frustrating. We’ve got a lot of scientists and doctors and laboratory personnel who are incredibly good at making assays. What we’re not so good at is figuring out all the forms and working with the bureaucracy of the federal government.

EUAs were intended to speed up the normal authorization process. But in this case, labs that were already conducting their own coronavirus tests needed to cease operations until they were granted an EUA. By declaring a public health emergency and not waiving EUA requirements, the FDA was actually slowing down the testing process.

Obtaining an EUA is no quick task. The FDA requires new protocols to be validated by testing at least five known positive samples from a patient or a copy of the virus genome. Most hospital labs have not even seen coronavirus cases yet. An article in GQ magazine detailed how Alex Greninger, an assistant director of the clinical virology laboratories at the University of Washington Medical Center, was forced to navigate a regulatory morass:

After emailing his application to the FDA, Greninger discovered that it was incomplete. It turned out that in addition to electronically filing it, he also had to print it out and mail a physical copy along with a copy burned onto a CD or saved to a thumb drive. That package had to be shipped off to FDA headquarters in Maryland. It was a strange and onerous requirement in 2020, but Greninger complied. He had no choice. On February 20, he overnighted the hard copies of his application to the FDA.

But submitting the physical application wasn’t the end of the process. Before granting the EUA, the FDA wanted Greninger to run his testing protocol against the MERS and SARS viruses:

Greninger complied. He called the CDC to inquire about getting some genetic material from a sample of SARS. The CDC, Greninger says, politely turned him down: the genetic material of the extremely contagious and deadly SARS virus was highly restricted.

“That’s when I thought, ‘Huh, maybe the FDA and the CDC haven’t talked about this at all,’” Greninger told me. “I realized, Oh, wow, this is going to take a while, it’s going to take several weeks.”

February 3: The FDA hosted a previously scheduled all-day conference at its headquarters with regulators, researchers, and industry leaders to “discuss the general process for putting diagnostic tests cleared under emergencies on the path to permanent approval by the FDA,” according to reporting by Reuters. “Though coronavirus was now the hottest topic in global medicine, a broadcast of the meeting conveyed little sense of urgency about the epidemic sweeping the globe” and the virus was only mentioned “in passing.”

February 4: The FDA issued an emergency use authorization (EUA) for the CDC’s test to be used at any CDC-qualified lab. Prior to issuing the CDC an EUA, all tests had been collected in the field and then shipped to CDC headquarters in Atlanta for analysis. During this time period, the CDC was able to run only about 500 tests (12 of which came back positive). To implement nationwide testing, the CDC would need to distribute its testing kits to partner labs across the country.

In a declared emergency, the FDA has broad discretion about which laboratory-developed tests will be permitted to be used. By only issuing a single EUA to the CDC, the FDA put all its eggs in one basket. Alan Wells, the medical director for the University of Pittsburgh Medical Center’s clinical laboratories, told the Wall Street Journal: “We had considered developing a test but had been in communication with the CDC and FDA and had been told that the federal and state authorities would be able to handle everything.”

February 5: The CDC began shipping test kits to about 100 state, city, and county public-health laboratories across the country, which would have allowed 50,000 patients to be tested. However, most of the partner labs ran into problems during the validation stage (which is necessary to ensure the tests were functioning properly), according to a ProPublica investigation:

The [CDC] shunned the World Health Organization test guidelines used by other countries and set out to create a more complicated test of its own that could identify a range of similar viruses. But when it was sent to labs across the country in the first week of February, it didn’t work as expected. The CDC test correctly identified COVID-19, the disease caused by the virus. But in all but a handful of state labs, it falsely flagged the presence of the other viruses in harmless samples.

The specific cause of these problems is still under investigation, but the initial findings suggest there were problems with one or more of the reagents used in the CDC testing kits. The CDC paused testing at its partner labs and resumed exclusive — and very limited — testing at its Atlanta headquarters.

February 10: The CDC notified the FDA about the reagent problems in the testing kits it had shipped to its partner labs. By not allowing private companies or public labs to use their own tests, the FDA had created a single point of failure and ultimately delayed large-scale testing by weeks. Keith Jerome, the lab director at the University of Washington, explained to The New Yorker why the FDA’s plan was vulnerable from the outset:

The FDA’s exclusive authorization to the CDC to conduct COVID-19 tests ended up creating “what you’d think of as an agriculture monoculture. If something went wrong, it was going to shut everything down, and that’s what happened.” Jerome said that his lab has taken its own steps to mitigate this problem. “We’ve built three completely independent testing pathways in our laboratory, so that if there’s a shortage of a reagent or a bit of plastic, we have other ways to do the testing.”

February 21: Nancy Messonnier, the director of the National Center for Immunization and Respiratory Diseases (NCIRD) at the CDC, told journalists that the issues with the reagents were still not resolved.

February 24: An association of more than 100 state and local health laboratories sent a letter to the FDA commissioner asking for “enforcement discretion” to use their own lab-developed tests. The chief executive of the association that sent the letter called it a “Hail Mary” pass and an act of desperation. The FDA directed the labs to submit an EUA application instead.

Between mid-January and February 28, the CDC produced more than 160,000 tests but used fewer than 4,000.

February 29: Facing a backlash to its rollout of testing, the FDA reversed its position and removed the requirement that advanced laboratories obtain prior emergency use authorization before using their own tests. At the time, this exemption applied only to “laboratories that are certified to perform high-complexity testing consistent with requirements under Clinical Laboratory Improvement Amendments.” One researcher estimated 5,000 virology labs in the country met this standard. For context, U.S. testing capacity includes approximately 260,000 laboratory entities.

March 3: Vice President Pence announced the CDC was lifting all federal restrictions on who can be tested for COVID-19: “Any American can be tested, no restrictions, subject to doctor’s orders.” Previously, testing was limited to only those who were exhibiting symptoms and had recently traveled to China or had been exposed to a known case. However, the supply of tests in particular regions would continue to be the most common binding constraint.

March 12: The FDA issued an EUA to Roche. Paul Brown, the head of Roche’s Molecular Solutions division, told The New Yorker, that “the company had been working on a test since February 1st” and that “the new tests, which are mostly automated, can make it possible for large testing companies such as Quest and LabCorp to test for COVID-19.” The CDC and state and local public health labs have been running tests manually. Reaching the scale of millions of tests will require automated tests on high throughput machines at large testing companies.

March 13: President Trump declared a national emergency. The FDA issued an EUA to Thermo Fisher.

March 15: HHS Secretary Azar waived sanctions and penalties against any covered hospital that does not comply with various provisions of the HIPAA Privacy Rule related to patient privacy and consent, including the need “to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care.” Previously, HIPAA privacy provisions and the Common Rule were holding up testing and the dissemination of information. According to an article in the New York Times, these kinds of requirements prevented labs from conducting coronavirus tests on samples collected for research purposes:

Federal and state officials said the flu study could not be repurposed because it did not have explicit permission from research subjects; the labs were also not certified for clinical work. While acknowledging the ethical questions, Dr. Chu and others argued there should be more flexibility in an emergency during which so many lives could be lost. On Monday night, state regulators told them to stop testing altogether.

On a phone call the day after the C.D.C. and F.D.A. had told Dr. Chu to stop, officials relented, but only partially, the researchers recalled. They would allow the study’s laboratories to test cases and report the results only in future samples. They would need to use a new consent form that explicitly mentioned that results of the coronavirus tests might be shared with the local health department.

They were not to test the thousands of samples that had already been collected.

March 16: The FDA expanded the EUA exemption to all commercial manufacturers and labs using new commercially developed tests, not just those that are certified to perform high-complexity testing under CLIA. The FDA also devolved regulatory oversight of these labs to the states. Wojtek Kopczuk, a professor of economics at Columbia University, quipped that the “FDA sped up the process by removing itself from the process.” The FDA also issued EUAs to Hologic and LabCorp. Co-Diagnostics, a molecular diagnostics company based in Utah, already had a test available in Europe and claimed it could supply 50,000 coronavirus tests per day going forward under the new FDA exemption. On Monday, government officials announced they were going to set up more drive-through testing centers. By the end of the week, they said they expect to have 1.9 million tests available thanks to high throughput automated machines at commercial labs.

Lessons learned.

In her call with reporters on February 21, Nancy Messonnier, who runs the CDC’s research on immunization and respiratory diseases, said: “We are working with the FDA, who have oversight over us, under the EUA, on redoing some of the kits. We obviously would not want to use anything but the most perfect possible kits, since we’re making determinations about whether people have COVID-19 or not.” This mentality is understandable coming from a regulator under ordinary circumstances. In normal times, and with non-highly contagious diseases, many of these regulations related to testing make sense. However, during a global pandemic, the risk calculus shifts. As Dr. Mike Ryan, executive director of the WHO’s health emergencies program, said in a press conference last week, when battling a new virus, “speed trumps perfection.”

The FDA did the right thing when it expanded the EUA exemption to all labs and manufacturers and devolved regulatory oversight to the states. The Department of Health and Human Services did the right thing when it waived certain provisions of the HIPAA Privacy Rule. But all of these actions were six weeks too late. Policymakers should consider implementing an automatic trigger so these decisions are made immediately upon the declaration of a public health emergency. COVID-19 will not be the last public health emergency. Speed, not perfection must be the focus of government agencies who are entrusted to protect the health of hundreds of millions of Americans. A distributed approach would be much more resilient to the inevitable mistakes and accidents inherent to pandemic response. Instead, in this crisis, the FDA bet big on a single testing protocol from the CDC and burned its ships. And when the “perfect” test failed spectacularly, everyone was left wishing for a way to retreat.

Alec Stapp is the director of technology policy at the Progressive Policy Institute.

Photograph by Al Drago/CQ-Roll Call/Getty Images.

*Correction, March 23, 2020: The piece originally misspelled Hubei Province.

 

source: https://thedispatch.com/p/timeline-the-regulationsand-regulatorsthat

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New York’s Ventilator Rationing Plan

By Betsy McCaughey

Coronavirus is causing working-age people to worry about missing paychecks, caring for kids home from school, stockpiling groceries and canceling plans. But people in their 50s, 60s or older have bigger worries. Many are lying awake wondering if this is how they’re going to die.

At its most severe, coronavirus attacks the lungs, making it impossible to breathe without a ventilator. Landing in the hospital on a ventilator is bad. But worse is being told you can’t have one. After learning that the state’s stockpile of medical equipment had 16,000 fewer ventilators than New Yorkers would need in a severe pandemic, Gov. Andrew Cuomo came to a fork in the road in 2015. He could have chosen to buy more ventilators. Instead, he asked his health commissioner, Howard Zucker to assemble a task force and draft rules for rationing the ventilators they already had.

That task force came up with rules that will be imposed when ventilators run short. Patients assigned a red code will have the highest access, and other patients will be assigned green, yellow or blue (the worst) depending on a “triage officer’s” decision. In truth, a death officer. Let’s not sugarcoat it. It won’t be up to your own doctor.

Cuomo could have purchased the additional 16,000 needed ventilators for $36,000 apiece or a total of $576 million in 2015. It’s a lot of money but less than the $750 million he threw away on a boondoggle “Buffalo Billion” solar panel factory. When it comes to state budget priorities, spending half a percent of the budget on ventilators is a no brainer.

Now the pandemic is actually here. Cuomo’s grim reaper rules will be applied. New York City’s deputy commissioner for disease control Demetre Daskalakis is anticipating “some very serious difficult decisions.” So far, in New York City, 1 out of every 4 people with a confirmed case has been hospitalized, and 44% of them have needed a ventilator.

The task force claimed there was no point in buying ventilators because there’s also a shortage of doctors and nurses trained to use them. Five years ago, that problem could have been fixed, too. Even now, the National Disaster Medical System can send staff to hot spots like New York.

In Wuhan, China, doctors recently faced the grim arithmetic of 1,000 patients needing ventilators and only 600 available. Italy’s rationing ventilators, too. Dr. Daniele Macchini, who practices in Italy, says “every ventilator becomes like gold.” Better than gold, if it keeps you alive.

But in New York, rationing ventilators should be unnecessary. The state knew of the shortage, had the money, and should have bought the lifesaving equipment, instead of making a plan on who should live or die.

U.S. manufacturers are making ventilators and filling orders from around the world.

In Italy, the death rate from coronavirus is a staggering 7%, more than double what’s occurring in many other countries. That’s partly because almost a quarter of Italy’s population is over 65 and especially vulnerable. The other reason is that Italy’s universal national health system promises free care but delivers stingy care. Italy has only around one-third as many intensive care beds per capita as the United States. Coronavirus patients are being turned away.

Expect the same dire results in the United Kingdom. The British National Health Service allocates about one-fifth as many intensive care beds per capita as American hospitals do. Bernie Sanders, are you watching? What’s happening in Italy and the U.K. is proof that single-payer is not the way to go.

Hospitals here in the U.S. will face severe challenges in the coming weeks, including shortages of space, equipment and personnel. But nothing compared with the extreme in Europe’s national health systems.

Americans don’t want government holding back the very things we need to survive. New York should never again decide to ration lifesaving equipment when it can be bought. That’s a lesson learned. Now’s not the time for political criticism. Now’s the time to get our sanitized hands on ventilators, no matter what.

Source: https://www.realclearpolitics.com/articles/2020/03/18/new_yorks_ventilator_rationing_plan_142685.html

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